Senior Medical Device Design Engineer (510k & Innovation)

Medline Industries, Inc.; Northfield (MN); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP is seeking a product design leader to manage multi-disciplinary teams responsible for the research, design, and development of new products and technologies. You will drive design specifications, coordinate timelines, and collaborate with customers, quality, regulatory, and manufacturing to ensure successful product launches.

Ideal candidates have 7+ years in product design, SolidWorks proficiency, and familiarity with medical device design controls and the 510(k) process.

Qualifications

• Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or software engineering.
• At least 7 years of experience in product design.
• Experience with SolidWorks/3D modeling software and prototype fabrication.
• Certified SolidWorks Professional (preferred).
• Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.

Responsibilities

• Manage multi-disciplinary product development teams to research, design, and develop new products and technologies.
• Collaborate with customers, quality, regulatory, legal, manufacturers, and divisional personnel to ensure new product designs meet all product requirements and experience a successful launch.
• Develop design specifications, manage multiple project timelines, and balance corporate priorities for product development projects to ensure that deadlines and goals are met.
• Coordinate product design and laboratory teams to ensure all design inputs are verified and validated.
• Contribute to new product designs, prototype generation/evaluation, and review technical drawings/specifications.
• Work with legal to design and implement new intellectual property.

Skills

SolidWorks

3D modeling

Prototype fabrication

Project management

Education

Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or software engineering

Tools

Microsoft Project

Job description

Medline Industries, LP is seeking a product design leader to manage multi-disciplinary teams responsible for the research, design, and development of new products and technologies. You will drive design specifications, coordinate timelines, and collaborate with customers, quality, regulatory, and manufacturing to ensure successful product launches.

Ideal candidates have 7+ years in product design, SolidWorks proficiency, and familiarity with medical device design controls and the 510(k) process.